MAUDE Adverse Event Report: CRYOLIFE, INC. HERO GRAFT; VASCULAR GRAFT

Model Number HERO 1001

Device Problem Insufficient Information (3190)

Patient Problem Impaired Healing (2378)

Event Date 01/21/2011

Event Type  Injury  

Event Description

According to the publication, experience of hero dialysis graft placement in a challenging population, a total of 11 patients underwent 12 hero graft implants.All of the patients had cvod to varying extents, including subclavian vein stenosis or occlusion, innominate vein stenosis and superior vena cava stenosis.All of these patients had multiple vascular accesses (catheters and av fistulas or grafts) placed prior to the hero, with a minimum of 2 and a maximum of >14.Only 3 patients had a history of bacteremia, leading to removal of their access prior to hero placement.Reasons for reintervention or failure (n=11): thrombosis (total of 5 events, number of failed grafts 4), local infection (total of 3 events, number of failed grafts 3), pseudoaneurysm (total of 2 events), seroma (total of 1 event), hematoma (total of 1 event) and nonhealing incision (total of 1 event).Associated with the local infection the paper added the following information "grafts removed due to abcess formation over graft." this medwatch is being submitted for the nonhealing incision event.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Manufacturer Narrative

According to the publication, "experience of hero dialysis graft placement in a challenging population," a total of 11 patients underwent 12 hero graft implants.All of the patients had cardiovascular occlusive disease (cvod) to varying extents, including subclavian vein stenosis or occlusion, innominate vein stenosis and superior vena cava stenosis.All of these patients had multiple vascular accesses (catheters and arteriovenous [av] fistulas or grafts) placed prior to the hero, with a minimum of 2 and a maximum of >14.Only 3 patients had a history of bacteremia, leading to removal of their access prior to hero placement.Reasons for re-intervention or failure (n=11): thrombosis (total of 5 events, number of failed grafts 4), local infection (total of 3 events, number of failed grafts 3), pseudoaneurysm (total of 2 events), bacteremia (total of 2 events), seroma (total of 1 event), hematoma (total of 1 event) and nonhealing incision (total of 1 event).Associated with the local infection the paper added the following information "grafts removed due to abscess formation over graft." this medwatch was submitted for the nonhealing incision.Additional information was received from the surgeon.From the additional information it was determined this event occurred in patient 5.Patient 5 was a female who had a hero graft (lot numbers unknown) implanted on (b)(6) 2010 and explanted on (b)(6) 2011 due to a local infection.The infection was identified on (b)(6) 2011 and the patient was cannulated during the infection.Blood culture results no growth; however, wound culture results light growth gram negative bacilli.The surgeon also reported complication with pseudoaneurysm.The pseudoaneurysm was identified on (b)(6) 2010 and the hero was cannulated during.A hematoma was also identified on (b)(6) 2010 and the hero was cannulated during hematoma.The hematoma was located on the left shoulder, overlying connection point between graft and catheter.The patient also had a non-healing incision which occurred on (b)(6) 2011.It was on the left shoulder, overlying connection point between the graft and the catheter.The patient passed away on (b)(6) 2012.Each event which occurred in patient 5 while a hero graft was implanted was investigated and separate medwatches were submitted for each.The ifu also lists infection and abnormal healing as potential complications.Infection is a known complication of prosthetic arteriovenous (av) grafts.The patient selection considerations listed in the hero graft ifu states the patient should be screened for infection and ensure infection is resolved prior to hero graft implant procedure.It also states to prophylactically treat the patient in the peri-operative period with antibiotics based upon the patient's bacteremia history.One case of a non-healing left shoulder incision was reported; the same patient was reported with a local infection with confirmed gram negative culture.Additionally, the publication reported that half of the patient population has documented diabetes, which is known to increase the risk of infection and/ or decrease the ability to fight off infection.Diabetes can also impair wound healing.The role of the hero graft in the infections is unknown; however, hero graft is terminally sterilized by a validated process making the hero graft unlikely to be the primary source of the infection.At this time, the role of the hero graft in these post-operative infections cannot be determined.The root cause for the reported events is unknown; however, all complications noted in the complaint are known potential complications of the hero graft.The ifu lists the following potential complications with the use of the hero graft: seroma, infection, vascular graft revision/replacement, partial stenosis or full occlusion of prosthesis or vasculature, pseudoaneurysm, hematoma, and abnormal healing.The hero graft is unlikely to be the direct source of the infection as the product undergoes a validated terminal sterilization process.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.

Event Description

According to the publication, experience of hero dialysis graft placement in a challenging population, a total of 11 patients underwent 12 hero graft implants.All of the patients had cvod to varying extents, including subclavian vein stenosis or occlusion, innominate vein stenosis and superior vena cava stenosis.All of these patients had multiple vascular accesses (catheters and av fistulasd or grafts) placed prior to the hero, with a minimum of 2 and a maximum of >14.Only 3 patients had a history of bacteremia, leading to removal of their access prior to hero placement.Reasons for reintervention or failure (n=11): thrombosis (total of 5 events, number of failed grafts 4), local infection (total of 3 events, number of failed grafts 3), pseudoaneurysm (total of 2 events), bacteremia (total of 2 events), seroma (total of 1 event), hematoma (total of 1 event) and nonhealing incision (total of 1 event).Associated with the local infection the paper added the following information "grafts removed due to abcess formation over graft." this medwatch is being submitted for the nonhealing incision.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144
• MDR Report Key: 4826381
• MDR Text Key: 21552436
• Report Number: 1063481-2015-00086
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention